高级法规注册事务专员_RAC_上海 上海

月薪：

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 02-26 发布
  • 做五休二
  • 绩效奖金
  • 节日福利
  • 专业培训
  • 五险一金
  • 带薪年假

职位描述

Job DescriptionJob Title: Senior RA SpecialistDepartment: RegulatoryJob Location: ShanghaiReport to: Senior Regulatory Affairs ManagerSubordinate: None POSITION SUMMARY Reporting to the Senior Regulatory Affairs Manage, works with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc. KEY RESPONSIBILITIES 1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely. 2. Acts as the Regulatory partner for the BU he/she is responsible for.…3. Interact with CFDA on registration requirements and monitor changes to requirements.4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision. 5. Manages a single discipline within the unit on a project or short-term basis.6. Interacts with manager as required by specific issues, milestones, or status changes.7. Represents BD externally in long term project in specific fields.8. Accepts accountability for RA within BD on multi disciplinary platforms.9. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.10. Ensures compliance with regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.11. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of. SKILLS AND ABILITIES 1. Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues. 2. Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and regions, particularly with regulators and Standard committee members. Independently authors written reports/documents for distribution within division.3. Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and provide input towards suitable actions.4. Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers.5. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.6. Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) in order to influence effectively and bring about consensus on policies that support business objectives.7. Minimum 3 years of directly related experience in medical device, or pharmaceutical fields, and three or more years of management experience.8. Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.9. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as technical or subject matter expert in multiple areas.10. Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.11. Independently manages and monitors multiple complex and diverse short term and long-term projects without direct supervision. Interacts with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required by specific events.12. Asserts own ideas and persuades others. Fosters collaboration among team members. Recognized as leader within department. 13. Formulates short term planning for individual deliverables/contributions and participates in long term planning within the department. DESIRABLE B.S. or B.A. degree in a technical discipline (electrical engineering, bioengineering, chemical, biology, pharmaceutical preferred). 职能类别： 药品注册 医疗器械注册

联系方式

中国上海市延安中路1228号静安嘉里中心

公司信息

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit www.bd.com. BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD在保护患者和医护人员安全、强化医学研究和临床实验室建设领域为行业所瞩目。公司提供创新的解决方案，以帮助推进医学和基因组学研究、加强传染性疾病和癌症的诊断、改善药物管理、促进感染预防、为手术和介入治疗提供工具，支持糖尿病管理。BD与全球范围内的机构组织携手，共同应对最具挑战的全球健康问题。公司在逾50个国家拥有分支机构，员工超过40,000人，公司与客户及合作伙伴紧密协作，以帮助改善医疗结果，降低医疗护理成本，提升效率，保护患者和医护人员安全并增加医疗可及性。更多信息，敬请访问www.bd.com/China。

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